Single catheter heart repair device and method for use

ABSTRACT

A system and method for repairing a human heart uses a catheter with an extendable tip and multiple tissue fasteners. The catheter is advanced into a human heart with the extendable tip adjacent a first tissue portion. The extendable tip is extended to form a tissue-receiving opening, the first tissue portion is positioned within the tissue-receiving opening, and the extendable tip is withdrawn to mechanically hold the first tissue portion. A first tissue fastener is secured to the first tissue portion, which is then released from the tissue-receiving opening. A second tissue fastener may subsequently be passed through a second tissue portion.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/932,939, filed Jul. 1, 2013, entitled “Single Catheter Mitral ValveRepair Device and Method for Use,” now U.S. patent Ser. No. ______,which is a continuation of U.S. patent application Ser. No. 13/584,476,filed Aug. 13, 2012, entitled “Single Catheter Mitral Valve RepairDevice and Method for Use,” now U.S. Pat. No. 8,475,472, which is acontinuation of U.S. patent application Ser. No. 13/027,045, filed Feb.14, 2011, entitled “Single Catheter Mitral Valve Repair Device andMethod for Use,” now U.S. Pat. No. 8,241,304, which is a continuation ofU.S. patent application Ser. No. 11/450,602, filed Jun. 9, 2006,entitled “Single Catheter Mitral Valve Repair Device and Method forUse,” now U.S. Pat. No. 7,887,552, which is a continuation of U.S.patent application Ser. No. 10/233,879, filed Sep. 3, 2002, entitled“Single Catheter Mitral Valve Repair Device and Method for Use,” nowU.S. Pat. No. 7,083,628. This application discloses subject matterrelated to U.S. patent application Ser. No. 09/562,406, filed May 1,2000, entitled “Minimally Invasive Mitral Valve Repair Method andApparatus,” now U.S. Pat. No. 6,626,930. The disclosures of all of theaforementioned United States patent applications are expresslyincorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

In vertebrate animals, the heart is a hollow muscular organ having fourpumping chambers: the left atrium, the left ventricle, the right atriumand the right ventricle. The atria are isolated from their respectiveventricles by one-way valves located at the respectiveatrial-ventricular junctions. These valves are identified as the mitral(or bicuspid) valve on the left side of the heart, and tricuspid valveon the right side of the heart. The exit valves from the left and rightventricles are identified as the aortic and pulmonary valves,respectively.

The valves of the heart are positioned in valvular annuluses thatcomprise dense fibrous rings attached either directly or indirectly tothe atrial and ventricular muscle fibers. Valve leaflets comprisingflexible collagenous structures are attached to, and extend inwardlyfrom, the annuluses to meet at coapting edges. The aortic, tricuspid andpulmonary valves each have three leaflets, while the mitral valve onlyhas two. In normal operation, the leaflets of the mitral valve open asleft ventricle dilates thereby permitting blood to flow from the leftatrium into the left ventricle. The leaflets then coapt (i.e. close)during the contraction cycle of the left ventricle, thereby preventingthe blood from returning to the left atrium and forcing the blood toexit the left ventricle through the aortic valve. Similarly, thetricuspid valve regulates flow from the right atrium into the rightventricle, and the pulmonary valve regulates blood exiting the rightventricle.

For a number of clinical reasons various problems with heart valves candevelop. One common form of heart disease involves the deterioration ordegradation of the heart valves, which leads to stenosis and/orinsufficiency. Heart valve stenosis is a condition in which the valvedoes not open properly. Insufficiency is a condition in which the valvedoes not close properly. Insufficiency of the mitral valve, most commonbecause of the relatively high fluid pressures in the left ventricle,results in mitral valve regurgitation (“MR”), a condition in which bloodreverses its intended course and flows “backward” from the leftventricle to the left atrium during heart contractions.

A number of surgical techniques have been developed to repair degradedor otherwise incompetent heart valves. A common procedure involvesreplacement of a native aortic or mitral valve with a prosthetic heartvalve. Such procedures require the surgeon to access the heart throughthe patient's chest (or possibly percutaneously), surgically remove theincompetent native heart valve and associated tissue, remodel thesurrounding valve annulus, and secure a replacement valve in theremodeled annulus. While these procedures can be very effective, thereare associated shortcomings. For example, the highly invasive nature ofthe implantation procedure typically results in substantial patientdiscomfort and requires patients to remain hospitalized for extendedrecovery periods. In addition, the two basic types of commerciallyavailable replacement valves, mechanical valves, and tissue valves, haveshortcomings of their own. Mechanical replacement valves typically offerextended operational lifetimes, but the patient is usually required tomaintain a regimen of anti-coagulant drugs for the remainder of his orher life. Tissue valves typically offer a higher degree of acceptance bythe body thereby reducing or eliminating the need for anti-coagulants,but the operational lifetimes of tissue valves is typically shorter thanmechanical valves and thus may require a subsequent replacement(s).

As an alternative to prosthetic heart valve replacement, it is oftenpreferable to remodel the native heart valve and/or surrounding tissue.Remodeling procedures often preserve left ventricular function betterthan mitral valve replacement because the subvalvular papillary musclesand chordae tendineae are preserved (most prosthetic valves do notutilize these muscles). Typically, valvular remodeling is accomplishedby implanting a prosthetic ring (“annuloplasty ring”) into the valveannulus to reduce and/or stabilize the structure of the annulus.Annuloplasty rings are typically constructed of a resilient core coveredwith a fabric sewing material. Annuloplasty procedures can be performedalone, or they can be performed in conjunction with other proceduressuch as leaflet repair. Although annuloplasty procedures have becomepopular and well accepted, reshaping the surrounding annulus andtraditional leaflet repairs do not always lead to optimum leafletcoaptation. As a result, some patients may still experience residualmitral valve regurgitation following annuloplasty procedures.

A recently developed technique known as a “bow-tie” repair has also beenadvocated for repairing insufficient heart valves, in particular themitral valve. The mitral valve bow-tie technique involves, in itssimplest form, suturing the anterior and posterior leaflets togethernear the middle of their coapting edges, thereby causing blood to flowthrough two newly formed side openings. While this does reduce thevolume of blood that flows from the atrium to the ventricle, this lossis more than compensated by improved leaflet coaptation, which reducesmitral regurgitation. As originally developed by Dr. Ottavio Alfieri,this process involved arresting the heart, and placing the patient onextra corporeal bypass and required invasive surgery to access andsuture the leaflets together. More recently, however, some haveadvocated a “beating heart” procedure in which the leaflets are accessedremotely and the heart remains active throughout the procedure.

A particular method for performing a beating heart bow-tie procedure(i.e. without extra corporeal bypass) has been proposed by Dr. MehmetOz, of Columbia University. The method and devices for performing themethod are described in PCT publication WO 99/00059, published Jan. 7,1999. In one embodiment of the disclosed procedure, the associateddevice consists of a forceps-like grasper used to grasp and hold themitral valve leaflets in a coapted position for suturing. Since themitral valve leaflets meet and curve toward and slightly into the leftventricular cavity at their mating edges, the grasper device is passedthrough a sealed aperture in the apex of the left ventricle. The edgesof the mating mitral valve leaflets are then grasped and held together,and a fastening device such as a clip or suture is utilized to fastenthem. The fastening device should be applied to the leaflet tissue withsufficient tissue purchase to prevent tear out or other failure, butclose enough to the edges to ensure that the newly created side holesare as large as possible. The Mehmet Oz disclosure thus illustrates thatteeth of the grasper device can be linearly slidable with respect to oneanother so as to permit alignment of the mitral valve leaflets prior tofastening. Since the procedure is done on a beating heart, it will bereadily understood that the pressures and motions within the leftventricle and mitral valve leaflets are severe. Thus the proceduretaught by Dr. Mehmet Oz is very skill-intensive.

The bow-tie technique has proved to be a viable alternative for treatingotherwise incompetent heart valves. Nonetheless, several shortcomingsassociated with current bow-tie procedures have been identified. Currentsystems include devices having mechanical graspers, barbed members, andvacuum devices that simultaneously capture and retain the valve leafletsprior to applying a fastening device thereto. Often, use of thesedevices results in the less than optimal leaflet stabilization andfastener placement. Many of these problems arise from the fact that thesurgeon is required to capture, retain and fasten the leaflets in onerelatively inflexible procedure. These difficulties are compounded whenthe leaflets are small or calcified making them difficult to pulltogether, and in beating heart procedures in which the leaflets areactively functioning throughout the surgery. In light of the foregoing,there is presently a need for improved systems for stabilizing multipletissue heart valve leaflets and placing a fastening device therebetween. More specifically, there is a present need for an improvedbow-tie procedure for repairing a patient's mitral valve.

BRIEF SUMMARY OF THE INVENTION

The single catheter mitral valve repair device of the present inventionmay be used to repair tissue throughout a patient's body. However, it isparticularly useful in repairing dysfunctional mitral valve tissue bystabilizing discreet valvular tissue pieces and deploying a fasteningdevice therethrough, thereby coapting the tissue pieces. The presentinvention may also be used to repair arterial septal defects (ASD),ventricular septal defects (VSD), and defects associated with patentforamen ovale (PFO).

In one aspect, the repair device of the present invention comprises anextendable engagement tip having at least one port formed thereon, atleast one deployable fastener in communication with the engagement tip,and one or more actuator members in communication with the port(s). Thedeployable fastener is capable of controllably engaging and fasteningtissue located proximal to the engagement tip.

In another aspect of the present invention, the repair device comprisesa handle, an elongated body, and an extendable engagement tip. Thehandle comprises a stationary handle body, an engagement tip actuator incommunication with the stationary handle body, a fastener deploymenthousing in communication with the stationary handle body, and a vacuumconnector capable of placing a vacuum source in communication with thestationary handle body. The elongated body comprises a flexible bodymember, at least one vacuum lumen, one or more actuation lumens and oneor more fastener lumens. Optionally, the elongated body can alsocomprise one or more auxiliary lumens. The one or more actuation lumensare capable of receiving one or more actuation members therein.Similarly, the one or more fastener lumens are capable of receiving atleast one deployable fastener therein. The extendable engagement tipcomprises a fastener deployment housing capable of attaching to theelongated body, an actuation flange attached to the fastener deploymenthousing, an extendable tip attached to the actuation flange and incommunication with the engagement tip actuator, a vacuum port incommunication with the vacuum connector, and at least one deployablefastener in communication with the fastener deployment housing.

The present invention also discloses a method of repairing tissue usingthe repair device of the present invention and comprises grasping afirst tissue portion with a vacuum force, stabilizing the first tissueportion with a mechanical force, deploying a tissue fastener into thestabilized first tissue portion, disengaging the first tissue portion,grasping at least a second tissue portion with a vacuum force,stabilizing at least a second tissue portion with a mechanical force,deploying at least a second tissue fastener into at least the secondstabilized tissue portion, disengaging at least the second tissueportion, and coapting the first tissue portion and at least the secondtissue portion with the first tissue fastener and at least the secondtissue fastener.

Other objects, features, and advantages of the present invention willbecome apparent from a consideration of the following detaileddescription.

BRIEF DESCRIPTION OF THE DRAWINGS

The apparatus of the present invention will be explained in more detailby way of the accompanying drawings, wherein:

FIG. 1 shows a perspective view of the mitral valve repair device of thepresent invention;

FIG. 2 shows a perspective view of the handle portion of the mitralvalve repair device of the present invention;

FIG. 3 shows a cross-sectional view of the handle portion of the mitralvalve repair device of the present invention;

FIGS. 4A and 4B show alternate cross-sectional views of the elongatedbody of the mitral valve repair device of the present invention:

FIGS. 5A and 5B show alternate perspective views of the engagement tipof the mitral valve repair device of the present invention;

FIG. 6 shows a cross-sectional view of the engagement tip of the mitralvalve repair device of the present invention;

FIGS. 7A and 7B show alternate perspective views of the engagement tipof the mitral valve repair device of the present invention in anextended position;

FIG. 8 shows a cross-sectional view of the engagement tip of the mitralvalve repair device of the present invention in a retracted positionwherein the deployable needle is deployed;

FIG. 9 shows a cross-sectional view of the engagement tip of the mitralvalve repair device of the present invention in a retracted positionwherein the deployable needle is retracted and is engaging a needlecatch;

FIG. 10 shows a perspective view of the mitral valve repair device ofthe present invention having attached fastener material to a firsttissue portion;

FIG. 11 shows a perspective view of the mitral valve repair device ofthe present invention having attached fastener material to a secondtissue portion;

FIG. 12 shows a perspective view of discreet tissue portions havingfastener material positioned therethrough; and

FIG. 13 shows a perspective view of discreet tissue portions beingcoapted with fastener material.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Disclosed herein is a detailed description of various embodiments of thepresent invention. This description is not to be taken in a limitingsense, but is made merely for the purpose of illustrating the generalprinciples of the invention. The overall organization of the descriptionis for the purpose of clarity only and is not intended to limit thepresent invention.

The single catheter mitral valve repair device of the present inventionis designed for use in a surgical treatment of bodily tissue. As thoseskilled in the art will appreciate, the exemplary single catheter mitralrepair device disclosed herein is designed to minimize trauma to thepatient before, during, and after a minimally invasive surgicalprocedure while providing improved tissue stabilization and enhancedplacement of a fastening device thereon. While the single cathetermitral valve repair device of the present invention may be used torepair tissue throughout a patient's body, it is particularly useful inrepairing dysfunctional mitral valve tissue by stabilizing discreetvalvular tissue pieces and deploying a fastening device therethrough,thereby coapting the tissue pieces. The present invention may also beused to repair arterial septal defects (ASD), ventricular septal defects(VSD), and defects associated with patent foramen ovale (PFO).

FIG. 1 shows the single catheter mitral valve repair device of thepresent invention. As shown, the repair device 10 comprises a handleportion 12 attached to an elongated body 14. An engagement tip 16 ispositioned on the distal portion of the elongated body 14. A vacuumconnector 18 is attached to the handle 12. As those skilled in the artwill appreciate, the present invention may be manufactured from avariety of materials including, without limitation, various metals,plastics, thermoplastics, silicones, elastomers, ceramics, compositematerials, or various combinations of the aforementioned materials. Forexample, the handle 12 may be manufactured from polyethylene, while theelongated body 14 is manufactured by an elastomer. In an alternateembodiment the elongated body 14, the engagement tip 16, or both mayincorporate radio-opaque or echogenic materials, thereby enabling thesurgeon to precisely position the repair device 10 within the patient'sbody.

FIG. 2 shows a perspective view of the handle 12 of the presentinvention. As shown in FIG. 2, the handle 12 comprises a stationaryhandle body 20 having a tip actuator 22 and a fastener deploymentactuator 24 in communication therewith. The tip actuator 22 and fastenerdeployment actuator 24 are movable relative to the stationary handlebody 20. Exemplary tip actuator members or fastener deployment housingsmay include, for example, buttons, levers, slidable fixtures, ortoggles. The distal portion of the stationary handle body 20 includes acoupling orifice 26 capable of receiving the elongated body 14 therein.In addition, the stationary handle body 20 may include a handle flange28 located thereon. The stationary handle body 20, fastener deploymentactuator 24, or tip actuator 22, may include at least one grip member 30positioned thereon. As shown in FIG. 2, a vacuum connector 18 is incommunication with the handle 12.

FIG. 3 shows a cross sectional view of the handle 12 of the presentinvention. As shown in FIG. 3, the stationary handle body 20 defines anactuation channel 32, which is in communication with the couplingorifice 26 formed on the distal portion of the stationary handle body20. The actuation channel 32 formed inside the stationary handle body 20is capable of receiving the tip actuator 22 and the fastener deploymentactuator 24 independently and in telescoping relation therein. Thoseskilled in the art will appreciate that the present invention permits auser to actuate the tip actuator 22 or the fastener deployment actuator24 independently. As shown, a bias member 34 may be positioned withinthe actuation channel 32 and may communicate in biasing relation withthe fastener deployment actuator 24. The tip actuator 22 is incommunication with at least one actuator extension member (see FIG. 7)positioned within one or more actuation lumens (see FIG. 4) formed inthe elongated body 14. Similarly, the fastener deployment actuator 24 isin communication with at least one fastener extension member (see FIG.6) positioned within one or more fastener lumens (see FIG. 4) formed inthe elongated body 14. The vacuum connector 18 is to be connected to anexternal vacuum source and is in fluid communication with the vacuumlumen 36 formed in the elongated body 14.

The elongated body 14 of the present invention may be manufactured in avariety of lengths or diameters as desired by the user. FIGS. 4A and 4Bshow cross-sectional views of two embodiments of the elongated body 14of the present invention. As shown in FIG. 4, the elongated body 14 ofthe present invention may comprise at least one vacuum lumen 36. In theillustrated embodiment, the vacuum lumen 36 is disposed in the center ofthe device; although those skilled in the art will appreciate that thepresent invention may be easily manufactured with the vacuum lumen 36positioned at various locations within or alongside the elongated body14. The body member 38 may further include one or more tip actuationlumens 40 a, 40 b, one or more auxiliary lumens 42, and one or morefastener lumens 44 formed therein. For example, FIG. 4B shows analternate embodiment of the present invention wherein the body member 38forms a vacuum lumen 36, tip actuation lumens 40 a, 40 b, auxiliarylumens 42, and two fastener lumens 44 a, 44 b therein. Those skilled inthe art will appreciate that the one or more auxiliary lumens 42 of thepresent invention are capable of receiving a guidewire, thereby enablingthe present invention to be directed to an area of interest in vivo witha guidewire. The elongated body 14 of the present invention may beattached to the handle 12 in a variety of manners, including, forexample, adhesively attached or in snap-fit relation.

FIG. 5A shows a perspective view of the engagement tip 16 attached tothe elongated body 14 of the present invention. The engagement tip 16comprises a fastener deployment housing 46, an extendable tip 48, and anactuation flange 50 in communication with the fastener deploymenthousing 46 and the extendable tip 48. The fastener deployment housing 46further includes at least one vacuum port 52 having a tissue support 54located therein, and a fastener deployment port 56 located thereon. Thetissue support 54 may comprise a series of vanes or other supportspositioned across or proximate to the vacuum port 52. The vacuum port52, positioned on the fastener deployment housing 46, is in fluidcommunication with the vacuum connector 18 positioned on the handle 12through the vacuum lumen 36 formed in the elongated body 14. Similarly,the fastener deployment port 56 is in communication with the fastenerdeployment actuator 24 located on the handle 12 through fastener lumen44 formed in the elongated body 14. In an alternate embodimentillustrated in FIG. 5B, a plurality of fastener deployment ports 56 maybe formed on the fastener deployment housing 46 and may be incommunication with a plurality of fastener lumens 44 formed in theelongated body 14 (see FIG. 4B). The extendable tip 48 of the presentinvention is in communication with the tip actuator 22 located on thehandle 12 through the actuation lumens 40 a, 40 b formed in theelongated body 14. The extendable tip 48 may include a fastener receiverport 58 capable of receiving the deployable tight 64 therein (see FIG.6). The fastener receiver port 58 is coaligned with or positionedproximate to the fastener deployment port 56 formed on the fastenerdeployment housing 46. The fastener receiving port 58 is capable ofreceiving the deployable needle 64 therein and includes a needle catch68 attached to fastener material 62 (see FIG. 6). The needle catch 68may comprise a variety of devices capable of engaging and retaining thedeployable needle 64 therein, including, for example, a ferruled orsized ring. In addition, the extendable tip 48 may include a fastenerchannel 60 capable of receiving fastener material 62 therein. Preferablythe fastener channel 60 is open on the distal end of extendable tip 48,as illustrated. Exemplary fastener materials include, for example,thread, wire, monofilament, braided filament, suture material, needles,sutures, staples, buttons, tissue-graspers, tissue clasps, barbs, andother tissue-coaption devices.

FIG. 6 shows a cross sectional view of the engagement tip 16. The vacuumport 52 is in fluid communication with the vacuum lumen 36. A deployableneedle 64 is in communication with the deployment housing 66 positionedwithin the fastener lumen 44. The receiver port 58 is in communicationwith the auxiliary lumen 42 located in the elongated body 14. A needlecatch 68, which is capable of engaging and retaining the deployableneedle 64, is attached to fastener material 62 which is positionedwithin the receiver port 58 and which extends through the auxiliarylumen 42 around the distal end of the engagement tip 16 and back towardsthe handle 12.

FIGS. 7A and 7B show the engagement tip 16 of the present invention inan extended configuration, thereby enabling the present invention tograsp and stabilize tissue located proximate thereto with a vacuumforce. As shown in FIG. 7A, actuation members 70 a, 70 b are slidablyreceived in the fastener deployment housing 46 and the extendable tip48, thereby permitting the extendable tip 48 to be moved, in telescopingrelation, relative to the fastener deployment housing 46. Exemplaryactuation members 70 a, 70 b may include, for example, rods, shafts, orconduits. The actuation members 70 a, 70 b communicate with the tipactuator 22 positioned on the handle 12 through the actuation lumens 40a, 40 b positioned in the elongated body 14. To actuate the extendabletip 48, the user advances the tip actuator 22 towards the stationaryhandle body 20, thereby advancing the actuation members 70 a, 70 b andresulting in the extendible tip 48 extending from the fastenerdeployment housing 46. To retract the extendible tip 48, the userretracts the tip actuator 22 away from the stationary handle body 20,thereby retracting the actuation members 70 a, 70 b and resulting in theextendible tip 48 retracting towards the fastener deployment housing 46.Those skilled in the art will appreciated that actuation of the tipactuator 22 results in the longitudinal movement of the actuation member70 a, 70 b positioned in the tip actuator lumens 40 a, 40 b of theelongated body 14, thereby resulting in the longitudinal extension andretraction of the extendable tip 48. FIG. 7B shows and alternateembodiment in which there are a plurality (two in the illustrated case)of deployment ports 56, fastener receiver ports 58 and correspondingfastener channels 60. FIG. 7B illustrates another alternate embodimentin which the faster material is stored within the vacuum lumen 36 (asopposed to the auxiliary lumen 42, see FIG. 6).

FIGS. 8 and 9 show cross sectional views of the engagement tip 16 of thepresent invention during use wherein a mechanical stabilization forcemay be applied to captured tissue. FIG. 8 shows a cross sectional viewof the engagement tip 16 wherein the deployable needle 64 has beendeployed from the fastener deployment port 56 located on the fastenerdeployment housing 46 through the fastener receiver port 58 and into theextendable tip 48. The deployable needle 64 is attached to thedeployment housing 66 positioned within the one or more fastener lumens44 of the elongated body 14. The deployment housing 66 is coupled to thefastener deployment actuator 24 positioned on the handle 12. To deploythe deployable needle 64, the user advances the fastener deploymentactuator 24 on the handle 12 towards the stationary handle body 20,which results in the longitudinal movement of the deployment housing 66within the fastener lumen 44 of the elongated body 14. Longitudinalmovement of the deployment housing 66 results in the deployable needle64 advancing through the fastener deployment port 56 into the fastenerreceiving port 58 and engaging the needle catch 68 located therein. Asshown in FIG. 8, the deployable needle 64 has engaged the needle catch68. The needle catch 68 is attached to the fastener material 62 locatedwithin the auxiliary lumen 42.

FIG. 9 shows a cross sectional view of the engagement tip 16 of thepresent invention wherein the deployable needle 64, having engaged andbeen retained by the needle catch 68 attached to the fastener material62, is positioned within the fastener lumen 44 of the elongated body 14.To retract the deployable needle, the user moves the fastener deploymentactuator 24 rearwardly away from the stationary handle body 20. As aresult, the deployment housing 66 moves in a reward longitudinal motionwhich results in the deployable needle 64, which is attached to thedeployment housing 66, moving rearwardly. The deployable needle 64,having the needle catch 68 and the fastener material 62 attachedthereto, retracts through the fastener receiving port 58 and enters thefastener deployment port 56. As shown in FIG. 9, the fastener material62 is in communication with the auxiliary lumen 42 and the fastenerlumen 44, thereby traversing the actuation flange 50. In an alternateembodiment of the present invention the extendable tip 48, the fastenerdeployment housing 46, or the elongated body 14 may include at least oneguidewire retaining device or lumen therein or attach thereto. In yetanother alternate embodiment, the positions of the needles and needlecatch are reversed (i.e. the needle moves from the extendable tip 48 toengage the needle catch in the port 56).

The present invention also discloses a method of using the singlecatheter mitral valve repair device of the present invention to repairdiscreet tissue portions in vivo. The description below describes amethod of repairing dysfunctional heart valves, however, those skilledin the art will appreciate that the present invention may be adapted foruse in other tissue repair procedures.

To repair a dysfunctional or otherwise incompetent heart valve, aguidewire capable of traversing the circulatory system and entering theheart of the patient is introduced into the patient through anendoluminal entry point. For example, an endoluminal entry point may beformed in a femoral vein or right jugular vein of a patient. Thereafter,the guidewire may be introduced into the patient through the endoluminalentry point and advanced through the circulatory system, eventuallyarriving at the heart. Upon arriving at the heart, the guidewire isdirected into the right atrium of the heart, traverses the right atriumand is made to puncture the atrial septum, thereby entering the leftatrium. The guidewire may then be advanced through the mitral valvewhile the heart is in diastole and traverses the left ventricle. Theguidewire traverses the aortic valve into the aorta and is made toemerge from the left femoral artery through an endoluminal exit point.This methodology of positioning a guidewire is known to physiciansskilled in the art of interventional cardiology. Once the guidewire ispositioned, the endoluminal entry or exit port is dilated to permitentry of a catheter therethrough. A protective sheath may be advanced inthe venous area to protect the vascular structure.

With the guidewire suitably anchored, the distal portion of the mitralvalve repair device of the present invention may be attached to theguidewire. Thereafter, the elongated body 14 having the engagement tip16 attached thereto is advanced through the dilated guidewire entry portto a point proximate the cusp portion of the mitral valve. Those skilledin the art will appreciate that the mitral valve repair device 10 of thepresent invention may approach the cusp of the mitral valve from anantegrade position or from a retrograde position as desired by the user.For a retrograde approach, the user attaches the repair device 10 to theguidewire emerging from the left femoral artery. The device is thenadvanced along the guidewire to a position proximate the retrogradeaspect of the mitral valve. The engagement tip 16 of the mitral valverepair device 10 may be positioned proximate the tissue portion 72 ofthe mitral valve. Once suitably positioned, the tip actuator 22positioned on the handle 12 may be actuated, thereby resulting in theextendable tip 48 of the engagement tip 16 extending distally from thefastener deployment housing 46. Thereafter, an external vacuum source(not shown) may be activated to apply a vacuum force to the mitral valverepair device 10 through the vacuum connector 18. The external vacuumsource (not shown) communicates with the vacuum port 52 located on theengagement tip 16 through the at least one vacuum lumen 36 in theelongated body 14. With the extendable tip 48 distally extended from thefastener deployment housing 46, the tissue portion 72 located proximateto the vacuum port 52 is grasped and retained by the vacuum forceapplied by the external vacuum source (not shown). Once the tissueportion 72 is captured by the vacuum force supplied through the vacuumport 52, the tip actuator 22 located on the handle 12 is actuated toretract the extendable tip 48 toward the fastener deployment housing 46thereby mechanically retaining and stabilizing the tissue portion 72therebetween. Once the tissue is sufficiently stabilized, the fastenerdeployment actuator 24 located on the handle 12 may be actuated todeploy a fastening device through the tissue portion 72. To deploy thefastener device the user advances the fastener deployment actuator 24toward the handle flange 28 positioned on the stationary handle body 20of the handle 12, thereby causing the deployable needle 64 to exit thedeployment port 56 and traverse the tissue positioned within theactuation flange 50. Thereafter, the deployable needle 64 enters thereceiver port 58 formed on the extendable tip 48 and engages the needlecatch 68 which is attached to the fastener material 62 positioned withinthe fastener channel 60. The fastener deployment housing 46 is returnedto a non-deployed position by the user, thereby resulting in thedeployable needle 64, which has retained the needle catch 68 attached tothe fastener material 60, returning to a non-deployed position withinthe fastener lumen 44 of the elongated body 14, and resulting in thetissue portion 72 having fastener material 62 positioned therethrough.As shown in FIG. 10, with the fastener material 62 positioned throughthe tissue portion 72, the external vacuum source may be deactivatedwhich results in the release of the captured tissue portion 72.Thereafter, the mitral valve repair device 10 of the present inventionis removed from the patient's body leaving a fastener material 62attached to the tissue portion 72.

Once removed from the body of the patient, the mitral valve repairdevice 10 may be reloaded with deployable need and fastener material,rotated, and reintroduced into the patient thereby permitting the deviceto apply additional tissue fasteners to bodily tissue adjacent thatalready fastened. At least the distal portion of the mitral valve repairdevice of the present invention is re-attached to the guidewire.Thereafter, the elongated body 14 having the engagement tip 16 attachedthereto is again advanced through the dilated guidewire entry port to apoint proximate the cusp portion of the mitral valve. The engagement tip16 of the mitral valve repair device 10 may be positioned proximate toanother tissue portion 74 of the mitral valve. The preceding process isthen repeated to secure suture material 62′ to tissue portion 74. FIG.11 shows the mitral valve repair device 10 positioned proximate to asecond tissue portion 74 located near the first tissue portion 72. Asshown, the fastener material 62′ is positioned through the tissueportion 74 and the external vacuum source may be deactivated whichresults in the release of the captured tissue portion 74. Thereafter,the mitral valve repair device 10 of the present invention is removedfrom the patient's body and may be removed from the patient's bodyleaving a fastener material 62′ attached to the tissue portion 74.Thereafter, the fastener material portions 62, 62′ may be joined tocoapt the individual tissue portions 72, 74. As shown in FIG. 12-13, aknot 76 is formed in the fastener material 62, 62′ and advanced to thetissue portions 72, 74. In one embodiment, the knot 76 is formedexternal the patient's body and advanced to the repair site with aknot-pushing device.

In the alternative embodiments of FIGS. 4B, 5B and 7B, the repair deviceneed not be removed from the patient between the steps of securing thefirst and second tissue pieces. The dual fastening system of thesealternate embodiments permits the faster material to be placedsequentially in both pieces of tissue simply by rotating the deviceafter securing the first piece of tissue. Lastly, one of skill in theart will understand that if the vacuum source is strong enough, and theneedle 64 sharp enough, extendable tip 64 need not translate relative tothe deployment housing 46 to mechanically hold the tissue in place. Thepieces of tissue can be held together in place with vacuum and puncturedwithout use of mechanical retention.

In closing, it is understood that the embodiments of the inventiondisclosed herein are illustrative of the principals of the invention.Other modifications may be employed which are within the scope of thepresent invention. Accordingly, the present invention is not limited tothat precisely as shown and described in the present disclosure.

What is claimed is:
 1. A device for repairing a heart valve in a beating heart of a patient, comprising: a handle assembly having a distal end; an elongated body extending from the distal end of the handle assembly and adapted to be advanced into the heart of the patient, the elongated body comprising a suture lumen extending longitudinally through the elongated body and adapted to receive a suture, the elongated body further comprising a needle lumen extending longitudinally through the elongated body; a tissue engagement assembly at a distal end of the elongated body and configured to be positioned in a native valve orifice within a beating heart, the tissue engagement assembly comprising a distally-facing surface comprising a needle port on a first side of the distally-facing surface, wherein the needle port forms a distal opening of the needle lumen, the tissue engagement assembly further comprising an extendable tip configured to be distally and telescopically extended via an actuation member from the distally-facing surface, wherein the extendable tip comprises a proximally-facing surface, the extendable tip further comprising a suture port on the proximally-facing surface, wherein the suture port is in communication with the suture lumen and is longitudinally aligned with the needle port, wherein the tissue engagement assembly is configured to grasp heart tissue between the distally-facing surface and proximally-facing surface by retracting the extendable tip toward the distally-facing surface; a suture portion passing through at least a portion of the suture lumen to a position adjacent the suture port; and a needle slidingly positioned within the needle lumen, the needle configured to be selectively and distally advanced out of the needle port and into the suture port to capture the suture portion, the needle configured to be retracted back into the needle port while drawing the suture proximally from the suture port into the needle port.
 2. The device of claim 1, further comprising a needle catch positioned at or adjacent the suture port and secured to the suture portion, wherein the needle captures the suture portion via the needle catch.
 3. The device of claim 1, wherein the extendable tip comprises a curved suture channel extending at least partially around a distal portion of the extendable tip and connecting the suture port to the suture lumen, wherein the suture portion passes from the suture lumen into the curved suture channel.
 4. The device of claim 3, wherein the curved suture channel of the extendable tip is at least partially open at a distal end of the extendable tip.
 5. The device of claim 3, wherein the suture portion comprises a single continuous loop of suture positioned in the suture lumen and suture channel, wherein the suture portion is looped such that a first section of the suture portion and a second section of the suture portion pass in parallel relationship through the suture lumen and suture channel.
 6. The device of claim 1, wherein the handle comprises a distal tip actuator configured to selectively advance and retract the distal tip.
 7. The device of claim 1, wherein the handle comprises a fastener deployment actuator configured to selectively advance and retract the needle.
 8. The device of claim 7, wherein the handle comprises a distal tip actuator configured to selectively advance and retract the distal tip, and the fastener deployment actuator is configured to be separately activated from the distal tip actuator.
 9. The device of claim 1, wherein the distally-facing surface comprises a vacuum port.
 10. A device for suturing tissue within a beating heart of a patient, comprising: a handle assembly; an elongated shaft extending from the handle assembly and adapted to be advanced into the heart of the patient via an opening at an apex of the heart, the elongated shaft comprising a suture lumen extending longitudinally through the elongated shaft and adapted to receive a suture, the elongated shaft further comprising a needle lumen extending longitudinally through the elongated shaft; a tissue grasping mechanism at a distal end of the elongated shaft and configured to be grasp tissue within the heart while beating, the tissue grasping mechanism comprising a distal end of the elongated shaft and an extendable tip, the tissue grasping mechanism comprising a needle port on a first side of the distal end of the elongated shaft, wherein the needle port is in communication with the needle lumen, the extendable tip configured to be distally and telescopically extended from the distal end of the elongated shaft, wherein the extendable tip comprises a rounded distal end and an actuation member, wherein the actuation member is positioned at a second side of the distal end of the elongated shaft that is opposite from the first side of the distal end of the elongated shaft, wherein the extendable tip comprises a suture port on a proximal side of the extendable tip, wherein the suture port is in communication with the suture lumen via a curved suture channel in the extendable tip, wherein the suture port is longitudinally aligned with the needle port, wherein the tissue capture mechanism is configured to grasp heart tissue between the distal end of the elongated shaft and the proximal side of the extendable tip by retracting the extendable tip toward the distal end of the elongated shaft; a suture line passing through at least a portion of the suture lumen to a position adjacent the suture port; a needle slidingly positioned within the needle lumen, the needle configured to be selectively and distally advanced out of the needle port and into the suture port to capture the suture line, the needle configured to be selectively retracted back into the needle port while drawing the suture line proximally from the suture port into the needle port.
 11. The device of claim 10, wherein the extendable tip comprises a curved suture channel extending at least partially around a distal portion of the extendable tip and connecting the suture port to the suture lumen, wherein the suture line passes from the suture lumen into the curved suture channel.
 12. The device of claim 11, wherein the curved suture channel of the extendable tip is at least partially open at a distal end of the extendable tip.
 13. The device of claim 11, wherein the suture line is looped such that a first section of the suture line and a second section of the suture line pass in parallel relationship to each other through the suture lumen and suture channel.
 14. The device of claim 10, further comprising a needle catch secured to the suture line and positioned at or adjacent the suture port, wherein the needle captures the suture line via the needle catch.
 15. The device of claim 10, wherein the handle comprises a distal tip actuator configured to selectively advance and retract the distal tip, the handle further comprising a fastener deployment actuator configured to selectively advance and retract the needle, wherein the fastener deployment actuator is configured to be activated separately from the distal tip actuator.
 16. A method of repairing a heart valve in a patient, comprising: providing a heart valve repair device having a handle, an elongated shaft, and an extendable tip, wherein the shaft comprises a needle lumen terminating in a needle port at a distal end of the shaft with a needle positioned in the needle lumen, the shaft further comprising a suture lumen, wherein the extendable tip comprises a suture port leading to a suture channel which leads to the suture lumen, the device comprising a suture portion passing from the suture lumen through the suture channel and adjacent the suture port; advancing the device into the patient until the shaft distal end is positioned within a heart valve annulus of the patient; distally extending the extendable tip from the shaft distal end; retracting the extendable tip toward the shaft distal end and thereby grasping a first tissue portion between the extendable tip and shaft distal end, wherein the first tissue portion is a first leaflet of the heart valve; distally advancing the needle through the first tissue portion and into the suture port; capturing the suture portion with the needle; retracting the needle from the suture port back into the needle port and thereby drawing the suture portion through the first tissue portion; and distally extending the extendable tip from the shaft distal end to thereby release the first tissue portion; passing the suture through a second tissue portion; tightening the suture to draw the first tissue portion toward the second tissue portion.
 17. The method of claim 16, wherein the second tissue portion is a second leaflet of the heart valve.
 18. The method of claim 17, wherein tightening the suture comprises drawing the first tissue portion into contact with the second tissue portion to coapt the first leaflet to the second leaflet.
 19. The method of claim 16, wherein the heart valve is a mitral valve.
 20. The method of claim 16, wherein the device is advanced into the patient's heart via an apex of the heart. 